MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	MC3302
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.D4: only di provided as lot number is unknown.Additional contact information: (b)(6).
Event or Problem Description
An event involving a 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave¿ clear, clamp, rotating luer reported that upon reconnection to the patient, the extension set directly attached to the arterial line noted to be back filling.Monitored and checked connection.After a few minutes, line continued to back fill and leak.Clamped line, removed and replaced with a new extension set.No further leaking or back filling noted.There was patient involvement and no harm/adverse event reported.

• Brand Name: 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24301616
• Report Number: 9617594-2026-00106
• Device Sequence Number: 12090898
• Product Code: FMG
• UDI-Device Identifier: 00887709037267
• UDI-Public: 00887709037267
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MC3302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown